A 6-month, Randomized, Double-blind, Placebo Controlled Study Evaluating the Efficacy and Safety of USPlus DERM to Promote Hair Growth in Men and Women With Self-perceived Thinning Hair.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in vellus hair counts from Baseline to Day 180 using the Canfield HairMetrix system.
研究概览
简要总结
The goal of this clinical trial is to substantiate the effectiveness and safety of USPlus® DERM for self-perceived thinning hair compared to placebo in healthy men and women ages 25-65 over the course of six months of continued use. Participants will be asked to have attend three office visits, one phone call, have photos taken of their hair and answer questionnaires related to their thinning hair.
详细描述
Hair shedding and thinning is presenting at alarming rates. It affects over 80% of men and 50% of women in the United States alone. As a multifactorial condition, while genetics is a small component, change in environmental exposures, nutrition, hormones, stress and lifestyle play significant roles. Currently, many individuals are looking for natural or prescription free options to combat challenges in hair thinning. One of the main ingredients added to current formulations is the natural supplement Saw Palmetto (Serenoa repens). To maintain thick full hair takes work, and prevention of hair thinning, shedding and hair loss requires early intervention. This study is performed to demonstrate the success of a long-standing supplement in the hair loss treatment armamentarium.
Oral medications come with significant side effects, and other modalities like laser and platelet rich plasma can be expensive to afford. Supplements therefore become a great natural alternative. Saw palmetto or Serenoa repens is a plant from the Areaceae family also known as Sabal serrulataa that acts as a competitive nonselective inhibitor of 5-alpha reductase (5αR) types I and II, which blocks the conversion of testosterone to its active metabolite, dihydrotestosterone. This process has been shown to help prevent miniaturization of hairs that lead to hair loss. Valensa International has analyzed the vast amount of science, as well as their own research data, to understand the impact of USPlus® DERM which contains concentrated lipidosterolic extracts of saw palmetto on hair health. The mechanism of action appears to prolong the anagen phase, tends to enhance dermal papilla, and maintains the follicle stem cell niche. USPlus® DERM is concentrated in bioactive free fatty acids (the building blocks of hair) and can help benefit hair health, the hair growth cycle and hair characteristics. Since hair loss has a multifactorial etiology, studying USPlus® DERM in the treatment
The purpose of this clinical research study is to evaluate the efficacy and safety of USPlus® DERM compared to placebo in sixty (60) healthy male and female subjects, 25-65 years of age with self-perceived hair thinning over the course of six (6) months of continued use.
Pre-Study Procedures
- Candidate subjects will be screened with selected eligibility requirements by telephone prior to Visit 1. The questions include the following: (1) Are you between the ages of 25-65? (2) Do you feel that your hair is thinning? 3) Are you able to attend periodic visits at your study doctor's office (3 visits and one phone call over a 6 month period)?
- Candidate subjects will be assigned an appointment time for visiting the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females of all Fitzpatrick Skin Types between 25 and 65 years of age.
- •Subjects must be willing to provide verbal understanding and sign an Informed Consent Form, HIPAA Form and Photography Release Form approved by the Institutional Review Board.
- •Subjects must be in general good health, as determined by the Investigator.
- •Subjects with self-perceived hair thinning as determined on initial study assessment by the Investigator (excluding patients with medically diagnosed telogen effluvium).
- •Subjects willing to undergo a brief physical exam to include height, weight, blood pressure, pulse, physical scalp exam and basic systems evaluation (Skin, Respiratory, Cardiovascular, Gastrointestinal, Endocrine, Neurological and Musculoskeletal systems) by the Investigator.
- •Male subjects with frontal and/or vertex patterns I, II, IIA, III, III vertex and IV during the physical scalp exam by the Investigator rated based on the Norwood Classification Scale.
- •Female subjects with I-1, I-2 and I-3 during the physical scalp exam by the Investigator rated based on the Savin Pictorial Scale.
- •Subjects willing to not substantially change their current diet, medications, dietary supplements and exercise routines for the duration of the study. If a subject receives physician guidance during the study to change diet, medications, supplements or exercise routine, the subject will need to notify the clinic as soon as possible.
- •Females of child bearing potential (FOCBP) must be willing to have a urine pregnancy test and practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months as of the start of the study, intrauterine device, condom with spermicide, diaphragm with spermicide, implant, NuvaRing®, injection, transdermal patch or abstinence.) Females on birth control pills must have taken the same type of pill for at least 3 months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least 3 months prior to the start of the study. The initiation of birth control should not have been associated with the initiation of hair loss/thinning.
- •FOCBP must have a negative urine pregnancy test at the Baseline Visit.
- •Subjects willing to have 2-D digital photography of the entire head/hair region for overall evaluation of general hair growth and quality by the Investigator.
- •Subjects willing to have digital trichoscopy photography of the target site areas on the scalp for analysis of hair counts and other hair measurements.
- •Subjects must be willing and able to complete and understand the rating questionnaires.
- •Subjects must maintain a consistent length, cut, style and color throughout the six (6) month study period.
- •Subjects who have color treated hair must be willing to have the color treatment performed at the same time interval prior to each visit (i.e. If on Visit 1 the color treatment was done one week prior then the color treatment is expected to occur at a similar interval of one week prior to Visits 2 and 3).
- •Subjects willing to maintain their normal hair shampooing frequency, use a mild non-medicated shampoo and conditioner for the duration of the study and attend visits with clean and dry hair (shampoo must be done 24 hours or more prior to the visit).
- •Subjects must be willing and able to attend all study visits and comply with the study product daily usage and lifestyle instructions.
排除标准
- •Subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study.
- •Male subjects with male pattern hair loss with frontal and/or vertex patterns IIIA, IVA, V, VA, VI, VII ratings using the Norwood Classification Scale as determined during the physical scalp exam by the Investigator.
- •Female subjects with I-4, II-1,II-2, III Advanced and Frontal ratings using the Savin Pictorial Scale as determined during the physical scalp exam by the Investigator.
- •Subjects who have had a hair transplant.
- •Subjects with hair extensions or who are planning on getting hair extensions during the duration of the study.
- •Subjects with any known allergy or sensitivity to any shampoo and/or conditioner.
- •Subjects with a known stressful incident within the last six months (e.g. death in family, miscarriage).
- •Subjects who have recently (within the last 3 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (3 months or longer) in order to be eligible for the study.
- •Subjects using Low Level Laser Therapy (LLLT) or other light therapy to treat thinning hair in the last 3 months.
- •Subjects who have regularly used Rogaine (Minoxidil), Nioxin and /or Finasteride or undergone any other hair or scalp treatments within the last 3 months.
- •Subjects who have used prescription drugs known to affect the hair growth cycle within the last 3 months (e.g., hormone-based birth control for less than 3 months, cyproterone acetate, aldactone/spironolactone or any 5-alpha-reductase inhibitor).
- •Subjects who have regularly used anti-androgenic therapies (i.e. spironolactone, flutamide, cyproterone acetate, progesterone and/or bicalutamide) or undergone any other hair or scalp treatments within the last 3 months.
- •Subjects suffering from other hair loss disorders, such as alopecia areata, scarring alopecia, androgenetic alopecia and telogen effluvium as determined during initial study assessment and physical scalp exam by the Investigator.
- •Subjects with self-reported uncontrolled diseases (i.e. diabetes, hypertension, hyperthyroidism, hypothyroidism, etc.). Whether medical conditions are under control with or without treatment will be assessed on an individual basis by the Investigator based on her medical and clinical expertise.
- •Subjects with self-reported active hepatitis, immune deficiency, HIV or autoimmune disease.
- •Subjects having a known active dermatologic condition of the scalp that may place the subject at a greater risk or interfere with clinical evaluations (ie. seborrheic dermatitis, psoriasis, atopic dermatitis, advanced skin cancer, etc.) as determined by the Investigator based on her medical and clinical expertise.
- •Subjects who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.
- •Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study.
- •Subjects with use of any medications that are known to potentially cause hair loss or affect hair growth as determined by the Investigator based on her medical and clinical expertise.
结局指标
主要结局
Change in vellus hair counts from Baseline to Day 180 using the Canfield HairMetrix system.
时间窗: Baseline to Day 180
Change in vellus hair counts from Baseline to Day 180 using the Canfield HairMetrix system.
Change in terminal hair counts from Baseline to Day 180 using the Canfield HairMetrix system.
时间窗: Baseline to Day 180
Change in terminal hair counts from Baseline to Day 180 using the Canfield HairMetrix system. A statistically significant increase in count at Day 180 in comparison to Baseline for subjects who were assigned to the Active compared to subjects who were assigned to the placebo indicates an improvement for the indicated parameter.
Change in total hair counts from Baseline to Day 180 using the Canfield HairMetrix system.
时间窗: Baseline to Day 180
Change in total hair counts from Baseline to Day 180 using the Canfield HairMetrix system. A statistically significant increase in count at Day 180 in comparison to Baseline for subjects who were assigned to the Active compared to subjects who were assigned to the placebo indicates an improvement for the indicated parameter.
次要结局
- Change in terminal to vellus ratio using the Canfield HairMetrix system from Baseline to Day 180.(Baseline to Day 180)
- Change in average hairs per follicular unit using the Canfield HairMetrix system from Baseline to Day 180.(Baseline to Day 180)
- Change in average hair width (μm) using the Canfield HairMetrix system from Baseline to Day 180.(Baseline to Day 180)
- Change in follicular units per cm² using the Canfield HairMetrix system from Baseline to Day 180.(Baseline to Day 180)
- Change in inter-follicular mean distance (mm) using the Canfield HairMetrix system from Baseline to Day 180.(Baseline to Day 180)
- Investigator Hair Quality Global Improvement Scale(Baseline to Day 180)
- Investigator Hair Growth Global Improvement Scale(Baseline to Day 180)
- Change in Hair Shedding Pull Test scores(Baseline to Day 180)
- Improvement in Hair Self-Assessment Questionnaire(Baseline to Day 180)
- Improvement in Hair Thinning Quality of Life Questionnaire(Baseline to Day 180)
- Favorable Analysis of the Hair Product Subject Satisfaction Questionnaire(Baseline to Day 180)